Dilation catheter structure

Description

[0001] The present invention pertains to dilation catheters of the so-called rapid exchange type with an inflatable balloon and with a lumen for a guide thread.

[0002] These catheters can be used in various operating and surgical procedures and/or for inserting molds, called stents, inside the ducts or lumens of a live body.

[0003] A dilation catheter generally comprises a thin and extended tubular element and usually has an inflatable balloon near its distal end, a first lumen for a guide thread and at least a second lumen for the passage of a fluid for inflating the balloon.

[0004] In the prior-art designs, the first and the second lumina of the catheter may be coaxial or not, may be made into a single extruded element, separated by a baffle, or formed by two small tubes of different diameter arranged one inside the other.

[0005] However, the current trend is to create a point for passing the guide thread in the catheter in a zone close to the distal end even though before, above, the inflatable balloon in order to reduce or preferably balance the sliding force of the catheter along the guide thread during the insertion in the body.

[0006] Various embodiments of dilation catheters have already been proposed in order to meet such a requirement.

[0007] In one embodiment, the catheter has a single extruded body, which has two integral lumina (e.g., EP-A-0 712 639) with one lumen for inflating the balloon and another lumen for the guide thread, this second lumen simply having a radial opening for the passage of the guide thread above the balloon.

[0008] According to another embodiment, a first and a second lumen of the catheter (e.g., US-A-5 102 403) are obtained, in a distal section from the front of the balloon of the catheter, by means of a longitudinal deformation of a starting tube which has a single lumen. The deformation is performed along a generating line of the tube and aimed at creating a lumen for the guide thread, which lumen has an opening on one side of the starting tube, which goes deep down to more or less on the axis of the said tube, and which opens at the distal end of same, while the lumen proper of the string tube opens into the ballon.

[0009] Further dilation catheters have been proposed in WO-A-94-4216, EP-A- 821981, US-A-5061273 and US-A-5387193.

[0010] Starting from these premises the object of the present invention is to propose a novel dilation catheter structure produced by means of an original configuration and combination of single tubular elements, therefore not in a single piece obtained from extrusion or deformed as taught by the prior art.

[0011] This object is accomplished with a dilation catheter according to claim 1, and which will be described here in detail below with reference to the attached drawings, in which:

Figure 1 shows a sectional view, before assembly, of parts of the tubes intended to form the catheter; and

Figure 2 shows a distal part of the assembled catheter and complete with balloon.

[0012] The catheter proposed here comprises a main tube 11, a distal tube 12, a guide tube 13 and a balloon 14.

[0013] The main tube 11 may be a single piece or comprise many tubular parts which are combined consecutively, perhaps different in terms of material and thickness or rigidity, so that the tube has a different flexibility or softness in various parts along its length.

[0014] The distal tube 12 is arranged as a continuation of the main tube 11, at the distal end 11' of same and the guide tube 13 is arranged in the distal tube 12. These two additional tubes 12, 13 may be of identical or different materials and thicknesses or rigidities, though different from those of the main tube.

[0015] As is shown in the drawing, the proximal end 12' of the distal tube 12 is flared so as to fit on the distal end 11' of the main tube and at the same time to enclose the proximal end 13' of the guide tube 13. Moreover, this same end 13' of the guide tube 13 is put on the outside of the distal end 11' of the main tube, on a part 11" which is deflected and inclined towards the axis of the tube itself, and for a greater robustness of the resulting unit, the guide tube 13 is made to pass in a lateral opening 11a provided in the main tube as shown in Figure 1.

[0016] The tubes 11, 12, 13 thus arranged and combined are then fixed to one another by means of a heat-sealing operation. To keep the tubes in shape in their zones to be sealed, and thus preventing their collapse and the blocking of their lumina, two expanders 15 and 16 are inserted into the main tube 11 and in the guide tube 13, respectively, which [expanders] are then extracted once the sealing has been performed.

[0017] In particular, the sealing is done in order to seal to one another the contact zones of the guide tube with the main tube and the outer distal tube all around the main tube and the guide tube. After this action, the expanders are extracted, and the initial ends of the guide tube and the distal tube are beveled in 17 as shown in the drawing.

[0018] It should be noted that the guide tube 13 extends beyond the front end of the distal tube 12. The balloon 14 is arranged around the guide tube and has two terminal necks 14', 14', one of which is sealed around the front end of the distal tube, the other is sealed around the distal end of the guide tube.

[0019] In the catheter thus constructed, the main tube 11 and the distal tube 12 together form a first axial lumen 18, which opens into the balloon 14; the guide tube 13 forms a second lumen 19 which has an opening on one side of the catheter, at the level of the bevel 17, and an axial opening at the front end of the guide tube itself.

[0020] The first lumen 18 is used to send an inflation fluid into the balloon, while the second lumen is used for passing a guide thread, which is usually used to facilitate the introduction of the catheter into the duct in question.

Claims

1. Dilation catheter structure provided with an inflatable balloon (14) and comprising a main tube (11), which has a distal end (11'), a distal tube (12) which has a proximal end (12') and a guide tube (13) which has a proximal end (13')
in which structure :

said main tube (11) and said distal tube (12) together form a first axial lumen (18), which opens into the balloon (14), to send an inflation fluid into the balloon,

said guide tube (13) forms a second lumen (19) for passing a guide thread,

Said guide tube (13) extends in said distal tube,

Said proximal ends (13', 12') of said guide tube (13) and of said distal tube (12) are joined to one another at said distal end (11') of said main tube (11), and said proximal end (13') of said guide tube (13) has an opening on one side of said main tube (11),

said proximal end (12') of said distal tube (12) encloses said distal end (11') of said main tube (11) and said proximal end (13') of said guide tube (13) tightly and simultaneously,

said distal end (11') of said main tube (11) has a lateral opening (11a),

said proximal end (13') of said guide tube (13) extends into said lateral opening (11a) of said main tube (11), and

said proximal end (12') of the said distal tube (12) is flared in order to peripherally reach both said distal end (11') of said main tube (11) and said proximal end (13') of said guide tube (13).

2. Catheter structure in accordance with claim 1 in which said distal end (11') of said main tube (11) has a part (11"), which is deflected and inclined towards the inside of said main tube (11), in which said proximal end (13') of said guide tube (13) rests on the outside of said inclined part (11") of said main tube (11), and in which said proximal end (12') of said distal tube (12) is flared in order to reach both said distal end (11') of said main tube (11) and said proximal end (13') of said guide tube (13) peripherally.

3. Catheter structure in accordance with claim 1 or 2, in which said proximal ends (13', 12') of said guide tube (13) and said distal tube (12) are joined to one another and to said distal end (11') of said main tube (11) by means of heat sealing.

4. Catheter structure in accordance with the above claims, in which said proximal ends of said guide and distal tubes are beveled at said lateral opening of the said main tube.

5. Catheter structure in accordance with the above claims, in which said guide tube (13) extends beyond the front end of said distal tube (12), and in which said balloon (14) is arranged between said two tubes, with a terminal neck (14") fixed to said guide tube and another terminal neck (14') fixed to said distal tube.

6. Catheter structure in accordance with the above claims, in which said main tube (11) and said distal tube (12) together form a first lumen for sending an inflation fluid into said balloon (14), and in which said guide tube (13) forms a second lumen for the passage of a guide thread.

7. Catheter structure in accordance with any of the above claims, in which said main tube (11) comprises one or more tubular sections of identical or different material, thicknesses and rigidities, and in which said guide tube (13) and said distal tube (12) are of materials, thicknesses and rigidities that are identical to or different from one another and with respect to the main tube (11).

8. Method for manufacturing a dilation catheter structure in accordance with claim 1, comprising the steps of:

providing an inflatable balloon (14);

providing a main tube (11) with a distal end (11');

providing a guide tube (13) with a proximal end (13');

providing a distal tube (12) with a flared proximal end (12');

providing a lateral opening (11a) on said main tube (11);

extending said proximal end (13') of said guide tube (13) into said lateral opening (11a);

enclosing said distal end (11') of said main tube (11) and said proximal end (13') of said guide tube (13) into said flared proximal end (12') of said distal tube;

inserting two expanders (15, 16) into said distal end (11') of said main tube (11) and into said proximal end (13') of said guide tube (13) to keep said tubes in shape in their zones to be sealed;

fixing said distal end (11') of said main tube (11), said proximal end (13') of said guide tube (13) and said flared proximal end (12') of said distal tube (12) to one another by means of a heat-sealing operation;

extracting said expanders (15, 16) once the sealing has been performed.

Ansprüche

1. Struktur eines Dilatationskatheters mit einem aufweitbaren Ballon (14) und umfassend einen Hauptschlauch (11), der ein distales Ende (11') aufweist, einen distalen Schlauch (12), der ein proximales Ende (12') aufweist, und einen Führungsschlauch (13), der ein proximales Ende (13') aufweist, wobei in dieser Struktur:

der Hauptschlauch (11) und der distale Schlauch (12) zusammen ein erstes axiales Lumen (18) bilden, welches sich in den Ballon (14) öffnet, um ein Fluid zum Aufweiten in den Ballon zu leiten,

der Führungsschlauch (13) ein zweites Lumen (19) zum Durchführen eines Führungsdrahtes bildet,

der Führungsschlauch (13) sich in den distalen Schlauch erstreckt,

die proximalen Enden (13', 12') des Führungsschlauchs (13) und des distalen Schlauchs (12) an dem distalen Ende (11') des Hauptschlauchs (11) miteinander verbunden sind, und das proximale Ende (13') des Führungsschlauchs (13) eine Öffnung an einer Seite des Hauptschlauchs (11) aufweist,

das proximale Ende (12') des distalen Schlauchs (12) das distale Ende (11') des Hauptschlauchs (11) und das proximale Ende (13') des Führungsschlauchs (13) fest und gleichzeitig umschließt,

das distale Ende (11') des Hauptschlauchs (11) eine seitliche Öffnung (11a) aufweist,

das proximale Ende (13') des Führungsschlauchs (13) sich in die seitliche Öffnung (11a) des Hauptschlauchs (11) erstreckt, und

das proximale Ende (12') des distalen Schlauchs (12) konisch erweitert ist, um am Umfang sowohl das distale Ende (11') des Hauptschlauchs (11) als auch das proximale Ende (13') des Führungsschlauchs (13) zu erreichen.

2. Katheterstruktur nach Anspruch 1, in welcher das distale Ende (11') des Hauptschlauchs (11) einen Bereich (11'') aufweist, der abgelenkt und in Richtung zur Innenseite des Hauptschlauchs (11) geneigt ist, in welcher das proximale Ende (13') des Führungsschlauchs (13) auf der Außenseite des geneigten Bereichs (11'') des Hauptschlauchs (11) ruht, und in welcher das proximale Ende (12') des distalen Schlauchs (12) konisch erweitert ist, um sowohl das distale Ende (11') des Hauptschlauchs (11) als auch das proximale Ende (13') des Führungsschlauchs (13) am Umfang zu erreichen.

3. Katheterstruktur nach Anspruch 1 oder 2, in welcher die proximalen Enden (13', 12') des Führungsschlauchs (13) und des distalen Schlauchs (12) miteinander und mit dem distalen Ende (11') des Hauptschlauchs (11) mittels Heißsiegeln verbunden sind.

4. Katheterstruktur nach den obigen Ansprüchen, in welcher die proximalen Enden des Führungsschlauchs und des distalen Schlauchs an der seitlichen Öffnung des Hauptschlauchs abgeschrägt sind.

5. Katheterstruktur nach den obigen Ansprüchen, in welcher der Führungsschlauch (13) sich über das vordere Ende des distalen Schlauches (12) hinaus erstreckt, und in welcher der Ballon (14) zwischen den zwei Schläuchen angeordnet ist, wobei ein Anschlusshals (14'') am Führungsschlauch befestigt ist und ein weiterer Anschlusshals (14') am distalen Schlauch befestigt ist.

6. Katheterstruktur nach den obigen Ansprüchen, in welcher der Hauptschlauch (11) und der distale Schlauch (12) zusammen ein erstes Lumen bilden, um ein Fluid zum Aufweiten in den Ballon (14) zu leiten, und in welcher der Führungsschlauch (13) ein zweites Lumen für den Durchgang eines Führungsdrahtes bildet.

7. Katheterstruktur nach einem der obigen Ansprüche, in welcher der Hauptschlauch (11) einen oder mehrere rohrförmige Abschnitte aus gleichem oder unterschiedlichem Material und mit gleicher oder unterschiedlicher Dicke und Steifigkeit aufweist, und in welcher der Führungsschlauch (13) und der distale Schlauch (12) aus einem Material bestehen und eine Dicke und Steifigkeit aufweisen, die gleich oder unterschiedlich voneinander und in Bezug auf den Hauptschlauch (11) sind.

8. Verfahren zur Herstellung einer Struktur eines Dilatationskatheters gemäß Anspruch 1, umfassend die Schritte:

Vorsehen eines aufweitbaren Ballons (14);

Vorsehen eines Hauptschlauchs (11) mit einem distalen Ende (11');

Vorsehen eines Führungsschlauchs (13) mit einem proximalen Ende (13');

Vorsehen eines distalen Schlauchs (12) mit einem konisch erweiterten proximalen Ende (12');

Vorsehen einer seitlichen Öffnung (11a) am Hauptschlauch (11);

Erstrecken des proximalen Endes (13') des Führungsschlauchs (13) in die seitliche Öffnung (11a);

Umschließen des distalen Endes (11') des Hauptschlauchs (11) und des proximalen Endes (13') des Führungsschlauchs (13) in dem konisch erweiterten proximalen Ende (12') des distalen Schlauchs;

Einsetzen von zwei Aufweitvorrichtungen (15, 16) in das distale Ende (11') des Hauptschlauchs (11) und in das proximale Ende (13') des Führungsschlauchs (13), um die Schläuche in ihren Zonen, die versiegelt werden sollen, in Form zu halten;

Befestigen des distalen Endes (11') des Hauptschlauchs (11), des proximalen Endes (13') des Führungsschlauchs (13) und des konisch erweiterten proximalen Endes (12') des distalen Schlauchs (12) aneinander mittels eines Heißsiegelvorgangs;

Herausziehen der Aufweitvorrichtungen (15, 16), sobald die Versiegelung durchgeführt wurde.

Revendications

1. Structure de cathéter de dilatation munie d'un ballon gonflable (14) et comprenant un tube principal (11), lequel comporte une extrémité distale (11'), un tube distal (12) qui comporte une extrémité proximale (12') et un tube de guidage (13) qui comporte une extrémité proximale (13') structure dans laquelle :

ledit tube principal (11) et ledit tube distal (12) forment ensemble une première lumière axiale (18), laquelle s'ouvre dans le ballon (14), pour envoyer un fluide de gonflage dans le ballon,

ledit tube de guidage (13) forme une seconde lumière (19) pour le passage d'un fil de guidage,

ledit tube de guidage (13) s'étend dans ledit tube distal,

lesdites extrémités proximales (13',12') dudit tube de guidage (13) et ledit tube distal (12) sont unies entre elles au niveau de ladite extrémité distale (11') dudit tube principal (11), et ladite extrémité proximale (13') dudit tube de guidage (13) porte une ouverture sur un côté dudit tube principal (11),

ladite extrémité proximale (12') dudit tube distal (12) inclut fermement et simultanément ladite extrémité distale (11') dudit tube principal (11) et ladite extrémité proximale (13') dudit tube de guidage (13),

ladite extrémité distale (11') dudit tube principal (11) possède une ouverture latérale (11a),

ladite extrémité proximale (13') dudit tube de guidage (13) s'étend à l'intérieur de ladite ouverture latérale (11a), dudit tube principal (11) et ladite extrémité proximale (12') dudit tube distal (12) est évasée en vue d'atteindre au niveau de leur périphérie à la fois ladite extrémité distale (11') dudit tube principal (11) et ladite extrémité proximale (13') dudit tube de guidage (13).

2. Structure de cathéter selon la revendication 1, dans laquelle ladite extrémité distale (11') dudit tube principal (11) comprend une partie (11''), qui est déviée et inclinée vers l'intérieur dudit tube principal (11), dans laquelle ladite extrémité proximale (13') dudit tube de guidage (13) repose sur l'extérieur de ladite partie inclinée (11'') dudit tube principal (11) et dans laquelle ladite extrémité proximale (12') dudit tube distal (12) est évasée en vue d'atteindre toutes deux de ladite extrémité distale (11') dudit tube principal (11) et de ladite extrémité proximale (13') dudit tube de guidage (13) au niveau de leur périphérie.

3. Structure de cathéter selon la revendication 1 ou 2, dans laquelle lesdites extrémités proximales (13',12') dudit tube de guidage (13) et dudit tube distal (12) sont unies entre elles et à ladite extrémité distale (11') dudit tube principal (11) au moyen d'un thermoscellage.

4. Structure de cathéter selon les revendications ci-dessus, dans laquelle lesdites extrémités proximales dudit tube de guidage et desdits tubes distaux sont chanfreinées au niveau de ladite ouverture latérale dudit tube principal.

5. Structure de cathéter selon les revendications ci-dessus, dans laquelle ledit tube de guidage (13) s'étend au-delà de l'extrémité avant dudit tube distal (12) et dans lequel ledit ballon (14) est disposé entre lesdits deux tubes, un col terminal (14'') étant fixé audit tube de guidage et un autre col terminal (14') étant fixé audit tube distal.

6. Structure de cathéter, selon les revendications ci-dessus, dans laquelle ledit tube principal (11) et ledit tube distal (12) forment ensemble une première lumière pour l'envoi d'un fluide de gonflage dans ledit ballon (14) et dans lequel ledit tube de guidage (13) forme une seconde lumière pour le passage d'un fil de guidage.

7. Structure de cathéter, selon les revendications ci-dessus, dans laquelle ledit tube principal (11) comprend une ou plusieurs sections tubulaires d'un matériau, d'épaisseurs et de rigidités identiques ou différentes et dans laquelle ledit tube de guidage (13) et ledit tube distal (12) sont de matériaux, d'épaisseurs et de rigidités qui sont identiques ou différents entre eux et par rapport au tube principal (11).

8. Procédé de fabrication d'une structure de cathéter de dilatation selon la revendication 1, comprenant les étapes consistant à :

fournir un ballon gonflable (14) ;

fournir un tube principal (11) comportant une extrémité distale (11') ;

fournir un tube de guidage (13) comportant une extrémité proximale (13') ;

fournir un tube distal (12) comportant une extrémité proximale évasée (12') ;

fournir une ouverture latérale (11a) sur ledit tube principal (11) ;

étendre ladite extrémité proximale (13') dudit tube de guidage (13) dans ladite ouverture latérale (11a) ;

inclure ladite extrémité distale (11') dudit tube principal (11) et ladite extrémité proximale (13') dudit tube de guidage (13) dans ladite extrémité proximale évasée (12') dudit tube distal ;

insérer deux dilatateurs (15,16) dans ladite extrémité distale (11') dudit tube principal (11) et dans ladite extrémité proximale (13') dudit tube de guidage (13) pour maintenir lesdits tubes en forme dans leurs zones à sceller ;

fixer ladite extrémité distale (11') dudit tube principal (11), ladite extrémité proximale (13') dudit tube de guidage (13) et ladite extrémité proximale évasée (12') dudit tube distal (12) entre elles au moyen d'une opération de thermoscellage ;

extraire lesdits dilatateurs (15,16) dès que le scellage a été effectué.

Drawing